Dr. Daniele Wikoff is the Director of ToxStrategies’ Health Sciences Practice and is based in Asheville, North Carolina. She specializes in the practice of evidence-based methods in support of hazard risk assessment applications. Dr. Wikoff has led the firm’s initiatives to integrate evidence-based methods as part of safety assessments for food ingredients and contaminants, industrial chemicals, and consumer products. She has successfully implemented a turn-key process for conducting systematic assessments at ToxStrategies, with a work flow facilitated by the combination of an experienced multidisciplinary team and use of systematic review software and tools. She has experience applying these methods to a wide range of agents (e.g., caffeine, TCE, TCDD, low-calorie sweeteners, sunscreens/oxybenzone), across evidence streams (human, experimental animal, mechanistic—including the key characteristics of carcinogens), to heterogeneous data sets (e.g., epidemiological data and high-throughput data), for a variety of outcomes (e.g., endocrine disruption, carcinogenicity).
Dr. Wikoff is well versed in frameworks from Cochrane, IOM, NTP-OHAT, EPA-TSCA and IRIS, EFSA/ECHA, and others—as well as tools and software—that are used to manage and facilitate the review process. She also routinely uses computational approaches to identify and evaluate evidence, integrating data from databases such as ToxRefDB and ToxCast/Tox21. Dr. Wikoff regularly employs both qualitative (e.g., AOP-based integration) and quantitative integration techniques (e.g., meta-analyses, Bayesian/meta-regression) to characterize hazard, points of departure, estimates of relative potency, and dose-response relationships. She is the lead author on a published framework for quantitatively integrating mechanistic data using the key characteristics of carcinogens. Dr. Wikoff has particular interest in methods development related to the definition and evaluation of data quality, and how elements of internal, construct, and external validity can be used to transparently inform conclusions and provide critical information to decision makers.
Dr. Wikoff is involved in a number of global collaborations to advance the practice of evidence-based toxicology, highlighted by her role as the Vice-Chair of the Science Advisory Council for the Evidence-Based Toxicology Collaboration (EBTC), membership on a National Academy of Sciences committee in the capacity of systematic review, and service as an Associate Editor for Toxicological Sciences in the area of systematic review. She has been an invited speaker and participant at systematic-review workshops hosted by the National Academics of Sciences, the European Food Safety Authority, and the U.S. Environmental Protection Agency. Dr. Wikoff is actively involved in efforts to advance methods related to problem formulation, evaluation of data quality (validity), and evidence integration. She is also a co-author of the World Health Organization’s systematic review guidance (under development), and she co-taught in a recent Continuing Education course on systematic review for the Society of Toxicology. Dr. Wikoff has presented on systematic review topics in a variety of scientific forums, including the Toxicology Forum and the Society of Risk Assessment. Dr. Wikoff is also an Associate Editor for Toxicological Sciences in the area of systematic review, and in a similar capacity for Regulatory Toxicology and Pharmacology.